Regulatory Affair Manager (Pharmacuticals - API)

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About Natural Biogenex Pvt. Ltd. (NBPL)

Natural Biogenex Pvt. Ltd. (NBPL), a subsidiary of Natural Capsules Limited, is committed to quality, compliance, and innovation. Our state-of-the-art facility in Tumkur, Karnataka, operates under stringent Good Manufacturing Practices (GMP), ensuring the highest quality standards for pharmaceutical ingredients.

To strengthen our Quality Control team, we are seeking a highly motivated and detail-oriented Executive QC who will play a crucial role in ensuring the quality, compliance, and accuracy of laboratory operations under cGMP and regulatory requirements.

Position Summary:

The Regulatory Affairs Manager oversees the regulatory submission processes, ensures compliance with all applicable regulations, and manages the regulatory strategy for pharmaceutical products. This role involves working closely with various departments, including R&D, Quality Assurance, and Marketing, to facilitate the development and commercialization of pharmaceutical products.

Key Responsibilities:

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Regulatory Strategy Development

• Develop and implement regulatory strategies for drug development and approval.
• Guide regulatory requirements and compliance to internal teams.

Submission Management

• Prepare and submit regulatory documents to health authorities (e.g., IND, NDA, BLA).
• Ensure timely and accurate submission of regulatory applications and amendments.

Communication with Regulatory Authorities

• Act as the primary point of contact with regulatory agencies.
• Manage and facilitate interactions with regulatory authorities, including meetings and responses to inquiries.

Regulatory Compliance

• Monitor changes in regulations and guidance to ensure compliance.
• Conduct audits and assessments to ensure adherence to regulatory requirements.

Cross-Functional Collaboration

• Work closely with R&D, Quality Assurance, and Marketing teams to ensure regulatory considerations are integrated into product development.
• Provide training and support to staff on regulatory processes and compliance.

Project Management

• Manage multiple regulatory projects simultaneously, ensuring timelines and deliverables are met.
• Coordinate with cross-functional teams to facilitate project milestones.

Documentation and Record-Keeping

• Maintain accurate records of regulatory submissions and communications.
• Prepare and review regulatory documentation for accuracy and completeness.

Qualifications:

• Education: Bachelors / Master&aposs degree in Organic Chemistry
• Experience: Minimum of 12 - 15 years of experience in regulatory affairs within the pharmaceutical industry for filing of products in various regulatory agencies.
• Knowledge: Strong understanding of regulatory guidelines and compliance requirements (FDA, EMA, etc.).
• Skills: Excellent communication, organizational, and project management skills. Ability to work collaboratively in a fast-paced environment.

Why Join Us

???? Be a part of a leading API manufacturing company with cutting-edge technology and compliance standards.

???? Work in a state-of-the-art Quality Control Laboratory with global regulatory standards.

???? Opportunity to contribute to regulatory audits and pharmaceutical quality excellence.

???? Competitive salary and professional development opportunities.